Raman spectroscopy for in situ, real time monitoring of protein aggregation in lyophilized biotherapeutic products

LC–MS based case-by-case analysis of the impact of acidic and basic charge variants of bevacizumab on stability and biological activity

(2021) Sumit Kumar Singh et al.   Scientific Reports

Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study

(2020) Srishti Joshi et al.   BIODRUGS

Impact of mAb Aggregation on its Biological Activity: Rituximab as a Case Study

(2020) Rohit Bansal et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Instability of therapeutic proteins — An overview of stresses, stabilization mechanisms and analytical techniques involved in lyophilized proteins

(2020) Arun Butreddy et al.   INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Analytical Platform for Monitoring Aggregation of Monoclonal Antibody Therapeutics

(2019) Rohit Bansal et al.   PHARMACEUTICAL RESEARCH

Drying Technologies for the Stability and Bioavailability of Biopharmaceuticals

(2018) Fakhrossadat Emami et al.   Pharmaceutics

Model-Based Methods in the Biopharmaceutical Process Lifecycle

(2017) Paul Kroll et al.   PHARMACEUTICAL RESEARCH

Immunogenicity of Therapeutic Protein Aggregates

(2016) Ehab M. Moussa et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Avoiding antibody aggregation during processing: Establishing hold times

(2014) Varsha Joshi et al.   Biotechnology Journal

Guidance for performing multivariate data analysis of bioprocessing data: Pitfalls and recommendations

(2014) Anurag S. Rathore et al.   BIOTECHNOLOGY PROGRESS

In Situ Protein Secondary Structure Determination in Ice: Raman Spectroscopy-Based Process Analytical Tool for Frozen Storage of Biopharmaceuticals

(2014) Ulrich Roessl et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Immunogenicity of therapeutic proteins: Influence of aggregation

(2013) Kirsty D. Ratanji et al.   Journal of Immunotoxicology

Protein Particulate Detection Issues in Biotherapeutics Development—Current Status

(2012) Tapan K. Das   AAPS PHARMSCITECH

Development of Stable Lyophilized Protein Drug Products

(2012) Richard L. Remmele et al.   CURRENT PHARMACEUTICAL BIOTECHNOLOGY

In Situ Monitoring of Proteins during Lyophilization using Micro-Raman Spectroscopy: A Description of Structural Changes induced by Dehydration

(2012) Alain Hédoux et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Discrimination between authentic and counterfeit banknotes using Raman spectroscopy and PLS-DA with uncertainty estimation

(2012) Mariana R. de Almeida et al.   MICROCHEMICAL JOURNAL

Chemometrics applications in biotech processes: Assessing process comparability

(2011) Nitish Bhushan et al.   BIOTECHNOLOGY PROGRESS

Protein aggregation—Pathways and influencing factors

(2010) Wei Wang et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development

(2010) John den Engelsman et al.   PHARMACEUTICAL RESEARCH

Immunogenicity of aggregates of recombinant human growth hormone in mouse models

(2009) Amber Haynes Fradkin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Current Perspectives on Stability of Protein Drug Products during Formulation, Fill and Finish Operations

(2008) N. Rathore et al.   BIOTECHNOLOGY PROGRESS